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A New Path Forward.

Canvas Dx is a Software as a Medical Device (SaMD) that aids physicians in diagnosing autism spectrum disorder (ASD) in young children1,2,3

Canvas Dx harnesses clinically validated artificial intelligence (AI) technology to aid physicians in diagnosing ASD in children between the ages of 18 and 72 months who are at risk of developmental delay4,5

Canvas Dx has the potential to facilitate early diagnosis in children with ASD4,5

How does Canvas Dx work?

Canvas Dx incorporates 3 separate, user-friendly inputs:

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A parent/caregiver questionnaire that asks about the child’s behavior and development collected via a parent/caregiver facing app3

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A questionnaire completed by a video analyst who reviews two videos of the child recorded by the parent/caregiver3

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A HCP questionnaire completed by a physician who meets with the child and a parent/caregiver, collected via a health care provider portal3

The Canvas Dx algorithm then evaluates all 3 inputs, generating a device output that the PCP utilizes in combination with their clinical judgement3,6

For Caregivers

User Guide

For Healthcare Providers

User Guide

*One of Canvas Dx’s device inputs is a 13-15 item age-dependent health care provider (HCP) questionnaire collected via a health care provider portal. Cognoa has contracted with a pediatric care provider to offer the option to have a qualified HCP complete the HCP questionnaire via a video visit with the caregiver and child, with the goal of allowing for a streamlined experience.

Why Canvas Dx?

Canvas Dx can aid PCPs in diagnosing ASD in children starting at 18 months of age during a critical period when interventions are shown to provide/lead to optimal long-term outcomes.7,8,9

While a child as young as 18 months can be reliably diagnosed with ASD, multiple factors have driven the average age of diagnosis to 4 years and 3 months, an average delay of 3 years between parental concern and a formal ASD diagnosis.10-19

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Long Wait Times

A shortage of specialists and time-intensive evaluations result in long wait times for diagnostic appointments, causing substantial delays in diagnosis.20,21

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Lack of access

Children who are non-white, female, from rural areas or from disadvantaged socioeconomic backgrounds are often diagnosed later than the average delay reported or missed altogether.15,17

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Delayed referrals

Because there is no standard diagnostic process for ASD and there are multiple types of specialists for referral, there is no clear pathway for PCPs.15,22

Because most ASD-specific interventions require a formal ASD diagnosis, delays can result in missed opportunities during a critical window in the child’s neurodevelopment18-20,22

How Canvas Dx Helps

How Canvas Dx Helps

Accurate

When used in conjunction with a physician's clinical assessment, Canvas Dx can accurately aid diagnosis starting at 18 months of age during a critical window in a child’s neurodevelopment. 10-12, 14, 23, 24

Efficient

By helping PCPs diagnose or rule out ASD, remotely or in person, Canvas Dx has the potential to expand the group of diagnosing physicians and may allow for more efficient specialty referrals.25,26,27

Consistent

In the Pivotal Study, Canvas Dx performed consistently across a diverse population. And because Canvas Dx can be used remotely, it may potentially reduce geographic barriers to care and expand diagnostic opportunities in underserved communities.25-28

How Canvas Dx Works

Canvas Dx harnesses the power of artificial intelligence (AI) to aid primary care physicians (PCPs) in the identification of autism spectrum disorder (ASD)29-32

AI uses pattern recognition to uncover clinically meaningful relationships that exist between signs, symptoms, and behaviors. In addition, AI approaches are suitable for aiding medical diagnosis. They unlock clinically relevant information hidden in massive amounts of healthcare data and identify complex non-linear patterns between patient features and diagnosis.33-47

Pivotal Study Results

The Canvas Dx pivotal study measured the performance of the device in aiding the diagnosis of autism spectrum disorder (ASD), compared to specialist evaluation using DSM-5 criteria.48,49

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The accuracy of Canvas Dx was assessed in comparison to the standard diagnostic approach (specialist evaluation and diagnosis) in a multisite, prospective, double-blinded, active comparator cohort study. The study included 425 children, aged 18-72 months, with parental or PCP concern for developmental delay.48,49

Canvas Dx performed consistently regardless of subjects’ gender, race/ethnicity, income levels, parental education levels demonstrating its potential to help address racial, ethnic, gender, and socioeconomic disparities in ASD diagnosis.48-52

Canvas Dx was shown to provide consistent performance across sex, racial and ethnic background, and socio-economic status.49,49

Canvas Dx met primary endpoints with a Negative Predictive Value (NPV) of 98.3% and a Positive Predictive Value (PPV) of 80.8% in those patients with a determinate result48,49*

NPV*

NPV*

98.3%

*NPV = Probability a child with a negative ASD result from Canvas Dx does not have ASD

PPV*

PPV*

80.8%

*PPV = Probability a child with a positive ASD result from Canvas Dx does have ASD (95% CI: 70%-89%)

Canvas Dx provided a “determinate result” (either positive or negative for ASD) 31.8% of the time.

When inputs were insufficient for rendering a high-confidence result, participants were provided with an “indeterminate” output. Of the 68.2% that were “indeterminate”, 91.0% were identified with one or more neurodevelopmental conditions 48,49, 53

 

Specialist Diagnosis of Participants Who Received Indeterminate Result

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Use of Canvas Dx may allow children with ASD to be diagnosed over 1.5 years earlier than the current average age of diagnosis49,54,55

The average age of children with a positive output in the Canvas Dx pivotal trial was 2.8 years, whereas the current average age of diagnosis is 4 years, 3 months.54,55